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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova deutschland manufactures the heater-cooler system 3t. The incident occurred in (b)(6). If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Through literature review livanova learned about a paper reporting a case of (b)(6) years old female patient infected with mycobacterium chimaera after aortic valve replacement surgery in 2010 and a heater-cooler system 3t was used. The patient presented to an outpatient care facility in (b)(6) 2015 with symptoms of an upper respiratory tract infection. She was prescribed antibiotics and systemic steroids which improved her symptoms. In (b)(6) 2016, she presented with malaise and intermittent fevers and was discovered to have anemia and acute kidney dysfunction but no obvious infection. An aortic root abscess was confirmed and she continued to deteriorate with worsening renal function and developed pancytopenia requiring red blood cell and platelet transfusions. Three weeks after hospitalization, her blood cultures were reported to be positive for mycobacterium and she was started on a four-drug regimen.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
14401 w. 65th way
arvada 80004
GM 80004
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada 80004
GM   80004
MDR Report Key10157653
MDR Text Key199070998
Report Number1718850-2020-01095
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-02-85
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/20/2020
Event Location No Information
Date Manufacturer Received05/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/16/2020 Patient Sequence Number: 1
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